Trial Information

Aim:

To evaluate the feasibility and safety of Endoscopic Submucosal Dissection (ESD) using
Master Slave Endoscopic Robotic System in humans.

Material and Methods:

To assess the feasibility and safety of ESD in humans, 3 patients with early gastric cancer
or sessile polyp in the stomach with no evidence of involvement of deeper layer will be
included in the study. The depth of involvement is evaluated by endoscopic ultrasound. An
informed consent about the nature of the procedure, complications and the need for surgery
will be explained to the patient. The master slave robot system (Human master robotic
interface, telesurgical workstation and slave manipulator) and forward viewing therapeutic
endoscope with 2 operating channels (GIF -2T160) will be used. The master controller
controls the slave manipulator with electrical cables through a software interface. The
slave manipulator in turn controls the end effectors (Monopolar 'L' hook and grasper)
through cables passed through the two operating channels of the endoscope. The master slave
robot system will be set up by the engineers from the Nanyang Technological University,
Singapore. The endoscope will be connected to the high definition visual display and will be
recorded throughout the procedure. Another high definition monitor will be set up for the
surgeon/endoscopist who will control the MASTER at the console and the movements at the
console will be continuously recorded. Monopolar electrocautery (ERBE) will be set up and
tested. The settings for cutting and blend will be the same as used in the conventional ESD.

The therapeutic endoscope and the end effectors will be sterilised by immersing the scope in
glutaraldehyde for 30 minutes before the procedure.

Patient will be kept fasting for 8 hours before the procedure. Under IV sedation, with the
patient in left lateral position, end viewing diagnostic gastroscope is passed with an
overtube. The lesion will be identified. Then the lesion will be marked by electrocautery
(ERBE) all around. Then Gelofusine® (containing 4% succinylated gelatin, sodium hydroxide)
stained with methylene blue will be injected submucosally under the lesion to create a
cushion for ESD. Then IT knife is used for the mucosal cut all around the lesion. The double
channel endoscope (GIF 2T160) will be exchanged through the overtube for the conventional
endoscope after checking the system. Then submucosal dissection of the lesion will be
performed, using the Master.

The data will be captured in the standard proforma for each patient. The endoscopic view and
the external view of the MASTER will be recorded throughout the procedure.

Analysis - Efficacy and Safety outcomes:

The ease of the procedure (grasping, retraction, triangulation and complete excision), time
required for mucosal cutting and submucosal dissection and completeness of the procedure
will be analysed. Safety outcomes include intraoperative, immediate postoperative
complications (bleeding, perforation) and the need for laparotomy will be assessed. Delayed
Complications if any will be recorded for up to 30 days after the procedure.

Statistical Methodology:

As this is a pilot study, no sample size calculation was done. The aim is to perform the
procedure in 3 subjects. Descriptive statistics will be used to describe safety data.

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